CLASS II Device recall · Reported 19 Jun 2019 · FDA Enforcement Report
Getinge 86-Series-Medical Washer-Disinfector recalled
Maquet Cardiovascular Us Sales is recalling Getinge 86-Series-Medical Washer-Disinfector, distributed nationwide in the US. The recall was initiated on 20 May 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1777-2019
- FDA event ID
- 82975
- Recalling firm
- Maquet Cardiovascular Us Sales, Wayne, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 May 2019
- FDA classified
- 13 Jun 2019
- Reported
- 19 Jun 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Other Medical Devices
Timeline
| 20 May 2019 | Recall initiated by company | |
| 13 Jun 2019 | Classified by FDA | +24 days |
| 19 Jun 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Possibility that inlet pump hose of the Washer Disinfector Getinge 86-Series (S-8666, S-8668) might collapse during use result in low water pressure within the circulation system and, in the worst case scenario, can result in the contents of the Washer Disinfector not being cleaned properly after finished process.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86662003 Product Usage: Usage: The Getinge 86 Series Medical Washer-Disinfector is designed for use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.
Where it was distributed
Worldwide Distribution - US Nationwide GA, IL, IN, MI, NC, OR, PA, VA Foreign: Australia, Canada, China, France, Germany, India, Japan, Korea, Netherlands, Saudi Arabia, South Africa, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, Ukraine
Nationwide GeorgiaIllinoisIndianaMichiganNorth CarolinaOregonPennsylvaniaVirginia
Questions about this recall
Why was it recalled?
Possibility that inlet pump hose of the Washer Disinfector Getinge 86-Series (S-8666, S-8668) might collapse during use result in low water pressure within the circulation system and, in the worst case scenario, can result in the contents of the Washer Disinfector not being cleaned properly after finished process.
Which lots are affected?
Serail Numbers: WAA088731, WAA089124 , WAA089128, WAA089586
Where was it sold?
Worldwide Distribution - US Nationwide GA, IL, IN, MI, NC, OR, PA, VA Foreign: Australia, Canada, China, France, Germany, India, Japan, Korea, Netherlands, Saudi Arabia, South Africa, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, Ukraine
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 82975| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Getinge 86-Series-Medical Washer-Disinfector recalled | Maquet Cardiovascular Us Sales | Foreign Material | Nationwide |
More recalls from Maquet Cardiovascular Us Sales
All 62| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | HLS Set Advanced recalled by Maquet Cardiovascular Us Sales | Maquet Cardiovascular Us Sales | Sterility | Nationwide |
| Device | CLASS II | HLS Set Advanced recalled by Maquet Cardiovascular Us Sales | Maquet Cardiovascular Us Sales | Sterility | Nationwide |
| Device | CLASS II | Blood Monitoring Unit (BMU recalled by Maquet Cardiovascular Us Sales | Maquet Cardiovascular Us Sales | Temperature Abuse | Nationwide |
| Device | CLASS II | Yuno II Mobile Operating Table recalled | Maquet Cardiovascular Us Sales | Foreign Material | Nationwide |
| Device | CLASS II | Yuno Mobile Operating Table recalled by Maquet Cardiovascular Us Sales | Maquet Cardiovascular Us Sales | Foreign Material | Nationwide |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |